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Today, the U.S. Food and Drug Administration permitted marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test. The U.S. Food and Drug Administration today authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants).

It is the first direct-to-consumer (DTC. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help. The FDA is authorizing the test to detect 33 variants for multiple genes. “This test is a step forward in making information about genetic variants available directly to consumers and better inform. The U.S. Food and Drug Administration (FDA) recently authorized the sale of a new direct-to-consumer (DTC) genetic test that can provide some limited information on the risk of breast, ovarian, or prostate cancer for a small subset of people.

The test is offered by the genetic testing company 23andMe as part of its health and ancestry service. By Taylor Lupo On April 6, the Food and Drug Administration (FDA) authorized 23andMe, a genetic testing service, to release Personal Genome Service Genetic Health Risk (GHR) tests. It’s the first time the FDA has approved a direct-to-consumer test for genetic predisposition to different conditions.

In March 2018, the Food and Drug Administration (FDA) announced its authorization of a direct-to-consumer (DTC) genetic test for three pathogenic BRCA1/2variants. We sought to determine to whether social media discussion increased following the authorization, who was driving social media conversations, and what topics were discussed. 23andMe’s GHR tests are the first DTC genetic tests authorized by FDA that provide individuals with information about their own risk of disease. Mountain View, California – March 6, 2018 – 23andMe, Inc., the leading personal genetics company, today received the first-ever FDA authorization for a direct-to-consumer genetic test for cancer risk. The authorization allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer.

Yesterday, the FDA approved the marketing of 23andME Personal Genome Service Genetic Health Risk (GHR), which tests for 10 different diseases. These are the first direct-to-consumer (DTC) tests approved by the FDA to provide information regarding genetic risks associated with certain diseases, according to a press release.

List of related literature:

Popular direct-to-consumer genetic tests also include testing for health risks and common traits.

“Genetics For Dummies” by Tara Rodden Robinson, Lisa Spock
from Genetics For Dummies
by Tara Rodden Robinson, Lisa Spock
Wiley, 2020

The FDA has actively solicited input on whether the current regulatory framework is appropriate for direct-to-consumer genetic testing.

“Genomic and Personalized Medicine: V1-2” by Geoffrey S. Ginsburg, Huntington F Willard
from Genomic and Personalized Medicine: V1-2
by Geoffrey S. Ginsburg, Huntington F Willard
Elsevier Science, 2012

As these tests are not subject to FDA oversight, the evaluation of the validity of genetic tests and products may be challenging for some consumers.

“Genomic and Personalized Medicine: V1-2” by Geoffrey S. Ginsburg, Huntington F Willard
from Genomic and Personalized Medicine: V1-2
by Geoffrey S. Ginsburg, Huntington F Willard
Elsevier Science, 2008

Direct-to-consumer genetic tests have significant risks and limitations.

“Lewis's Medical-Surgical Nursing: Assessment and Management of Clinical Problems” by Diane Brown, Helen Edwards, Lesley Seaton, Thomas Buckley
from Lewis’s Medical-Surgical Nursing: Assessment and Management of Clinical Problems
by Diane Brown, Helen Edwards, et. al.
Elsevier Health Sciences, 2017

A 2008 study by the Department of Health and Human Services Secretary’s Advisory Committee on Genetics, Health, and Society projected that over 60% of the population within the USA may eventually benefit from the results of genetic analysis [6].

“Utilization Management in the Clinical Laboratory and Other Ancillary Services” by Kent Lewandrowski, Patrick M. Sluss
from Utilization Management in the Clinical Laboratory and Other Ancillary Services
by Kent Lewandrowski, Patrick M. Sluss
Springer International Publishing, 2016

Recently, the FDA has shown that the premarket approval regime is minimally workable: it approved one company to sell a genetic test for a particular condition, Bloom Syndrome, which is quite rare (U.S. Food and Drug Administration 2015).

“Nudging Health: Health Law and Behavioral Economics” by I. Glenn Cohen, Holly Fernandez Lynch, Christopher T. Robertson, Cass R. Sunstein
from Nudging Health: Health Law and Behavioral Economics
by I. Glenn Cohen, Holly Fernandez Lynch, et. al.
Johns Hopkins University Press, 2016

FDA, FDA Allows Marketing of First Direct-to-Consumer Tests That Provide Genetic Risk Information for Certain Conditions, April 6, 2017, available at: www.fda.gov (noting as well the specific regulatory pathways used to consider and approve the DTC genetic tests).

“Health Care Law and Ethics” by Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley, I. Glenn Cohen
from Health Care Law and Ethics
by Mark A. Hall, David Orentlicher, et. al.
Wolters Kluwer, 2018

Direct to Consumer Testing Traditionally, genetic tests have been available only through health care providers, such as physicians, nurse practitioners, and genetic counselors, who identify the most appropriate testing and interpret the test results.

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from Ethical and Legal Issues in Canadian Nursing E-Book
by Margaret Keatings, Pamela Adams
Elsevier Health Sciences, 2019

The federal government has established guidelines on the marketing and advertising of DTC genetic tests by prohibiting some types of marketing and permitting the sale of low risk tests and certain advertising claims.

“Nutrition in Lifestyle Medicine” by James M. Rippe
from Nutrition in Lifestyle Medicine
by James M. Rippe
Springer International Publishing, 2016

FDA allows marketing of first direct-toconsumer tests that provide genetic risk information for certain conditions.

“Integrative Gastroenterology” by Gerard E. Mullin, Marvin Singh
from Integrative Gastroenterology
by Gerard E. Mullin, Marvin Singh
Oxford University Press, 2019

Alexia Lewis RD

Registered Dietitian Nutritionist and Certified Heath Coach who believes life is better with science, humor, and beautiful, delicious, healthy food.

[email protected]

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